A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase IIa/IIb Study to Evaluate the Safety, Tolerability, and Efficacy of NP-101 in Treating High-Risk Participants Who Have Tested Positive for Novel Coronavirus 2019

Kaseb et al., NCT05785390, BOSS-002, NCT05785390, Aug 2026
Early treatmentDouble-blind RCT · NCT05785390 · 110 patients · USA
Nigella Sativa for COVID-19
BOSS-002 Kaseb et al. NCT05785390 · August 2026
Lower progression with nigella sativa
p = 0.0065

Nigella Sativa for COVID-19

13th treatment shown to reduce risk in January 2021, now with p = 0.00003 from 15 studies.
Lower risk for ventilation, hospitalization, progression, recovery, cases, and viral clearance.

No treatment is 100% effective.
Protocols combine treatments.

6,700+ studies · 220+ treatments

c19early.org
Meta-analysis
RCT 110 high-risk outpatients showing significantly lower COVID-19 progression with NP-101 (thymoquinone from Nigella sativa with fatty acids, including palmitic, oleic, and linoleic acids), but no significant difference for the primary day-5 sustained-recovery endpoint. Long COVID risk was lower, without reaching statistical significance (RR=0.58, p=0.07). There were no deaths, serious adverse events, or hospitalizations in either arm, and there were fewer adverse events with treatment (19/50 vs. 32/60). Currently results are only available in the registry.
Standard of Care (SOC) for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments1. Only expensive, high-profit treatments were approved for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
Important missing comments or errors? Let us know.
risk of progression, 60.0% lower, RR 0.40, p = 0.006, treatment 8 of 50 (16.0%), control 24 of 60 (40.0%), NNT 4.2, symptom progression, defined as worsening from none/mild to moderate/severe for >=2 days, or hospitalization/death due to COVID-19 worsening, day 28.
risk of long COVID, 41.8% lower, RR 0.58, p = 0.07, treatment 12 of 49 (24.5%), control 24 of 57 (42.1%), NNT 5.7, long COVID symptoms reported on any assessment at days 30, 37, or 45.
risk of no recovery, 10.0% higher, RR 1.10, p = 0.70, treatment 22 of 50 (44.0%), control 24 of 60 (40.0%), failure to achieve sustained clinical recovery by day 5, day 5.
recovery time, 25.0% higher, relative time 1.25, p = 0.70, treatment 5.0 [4.0-5.0] n=50, control 4.0 [4.0-5.0] n=60, median days to sustained clinical recovery.
recovery time, 12.2% lower, relative time 0.88, p = 0.63, treatment 18.0 [7.0-23.0] n=50, control 20.5 [12.0-25.0] n=60, median days to complete clinical recovery.
recovery time, 19.1% lower, relative time 0.81, p = 0.35, treatment 19.0 [11.0-27.0] n=50, control 23.5 [16.0-27.0] n=60, median days to complete clinical resolution.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Kaseb et al., 13 Aug 2026, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT05785390 (history) (BOSS-002). Contact: akaseb@novatekpharmaceuticals.com.
$0 $500 $1,000+ Efficacy vs. cost for COVID-19 treatment protocols c19early.org October 2026 USA Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines Vietnam Japan Argentina Nepal Iran Bangladesh Ethiopia Ghana Germany Mexico South Korea United Kingdom Saudi Arabia Algeria Morocco Yemen Poland Uzbekistan India China Venezuela DR Congo Madagascar Thailand Uganda Egypt Nigeria Taiwan Fiji Zambia Bosnia-Herzegovina Jordan Georgia Switzerland Dominican Republic Bolivia Côte d'Ivoire Eritrea Togo Bulgaria Greece Slovakia Iceland New Zealand Trinidad and Tobago Mongolia Czechia Belarus Israel Haiti North Macedonia Hong Kong Qatar Panama Serbia USA favored high-profit treatments.The average efficacy of treatments was very low.High-cost protocols reduce early treatment, andforgo complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
$0 $500 $1,000+ Efficacy vs. cost for COVID-19treatment protocols worldwide c19early.org October 2026 USA Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines Vietnam Japan Argentina Nepal Iran Bangladesh Ethiopia Ghana Germany Mexico South Korea United Kingdom Saudi Arabia Algeria Morocco Yemen Poland Uzbekistan India China Venezuela DR Congo Madagascar Thailand Uganda Egypt Taiwan Fiji Zambia Jordan Georgia Switzerland Dominican Rep. Bolivia Côte d'Ivoire Eritrea Togo Sri Lanka Bulgaria Greece Slovakia New Zealand Trinidad and Tobago Mongolia Czechia Belarus Israel North Macedonia Hong Kong Qatar Panama Serbia USA favored high-profit treatments.The average efficacy was very low.High-cost protocols reduce early treatment,and forgo complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
Please send us corrections, updates, or comments. c19early involves the extraction of 200,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. IMA and WCH provide treatment protocols.
  or use drag and drop   
Submit    
Post
Share
@CovidAnalysis
FAQ
Public domain CC0 1.0